The wrongful death lawsuit was filed against PharmaTech LLC by Jocelyn and Lamont Singleton on behalf of their 2 year-old daughter, Alivia, who died on May 4, 2016 after being given Diocto Liquid.
The lawsuit alleges that Alivia developed a deadly infection with the bacteria Burkholderia cepacia in a contaminated bottle of Diocto Liquid Stool Softener manufactured by PharmaTech LLC.
Alivia was given Dioto Liquid at the Children’s Hospital of Pittsburgh to treat constipation from her pain medication. She developed an infection in February 2016, but doctors couldn’t figure out why.
After Alivia’s death, her mother learned of a nationwide recall of the same Diocto Liquid laxative Alivia was given. The family soon filed a lawsuit against PharmaTech LLC and Rugby Laboratories in the U.S. District Court for the Western District of Pennsylvania.
The FDA issued an advisory in 2016 after an outbreak of B. cepacia infections were traced to liquid laxatives. There were 63 confirmed infections and 45 suspected cases in 12 states.
Last week, the FDA reported that lab findings again linked Rugby Diocto oral liquid docusate sodium to B. cepacia infections:
FDA testing has identified Burkholderia cepacia in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech LLC, Davie, Florida.”
Other bacteria, yeast, and mold contaminants were also found in the PharmaTech docusate sodium oral liquid samples tested by FDA. PharmaTech sells liquid laxatives under a variety of brand-names, including Rugby, Leader, Major, Centurion, and Mid Valley.
FDA reminded health care professionals and patients not to use any liquid product manufactured by PharmaTech’s Davie, Florida, facility.
PharmaTech vacated the building in June, according to a spokesman. Their phone number is disconnected and the website is offline.
Federal health officials opened an investigation into the outbreaks in June 2016, one month after Alivia died. In July, PharmaTech recalled all of its Diocto Liquid laxatives after the FDA confirmed that an unopened bottle was contaminated with Burkohlderia cepacia.
PharmaTech wants the lawsuit dismissed because it “lacks specificity,” but lawyers for the Singleton family say the claims are legitimate.
Source: FDA updates on 2017 Burkholderia cepacia contamination